Adverse Clinical Events Associated with the Use of Anti-snoring Devices

Background: With the recent interest and growth of sleep medicine, oral devices are used increasingly to treat patients suffering from snoring and Obstructive Sleep Apnea (OSA). The main advantages of using removable oral devices to address snoring and OSA are the relative simplicity of the treatment and cost-effectiveness. Although promising, little is known about the risk of adverse outcomes associated with the use of removable oral devices for snoring and OSA. The objective of this study is to analyze the adverse events reported to the Manufacturer and User Facility Device Experience (MAUDE) database that are associated with the use of removable oral anti-snoring devices and actions taken by the manufacturer to address these events. Methods: The study analyzed the MAUDE database of the United States Food and Drug Administration (FDA). Data were collected from reports pertaining to removable oral anti-snoring devices. The variables documented were “type of event,” “signs and symptoms of the patient,” “reporter occupation,” and “type of adverse event.” Results: A total of 326 cases were recorded during the study period. The most common adverse events were malfunction, followed by injury, which affected 48.5% (158) and 48.2% (157) of the patients, respectively. Device breakage was documented in 22.2% (72)of patients. In 3.3% (11) of the cases, part of the oral device was swallowed by the patient during sleep, therefore posing a choking hazard. The most common patient problem was hypersensitivity/allergic reaction seen in 29.0% (95) of patients. 9.8% of these patients already had a known allergy to drugs, metal or other materials. Conclusion: Taking a detailed health history of the patient could help prevent many of these adverse events.